Summary of medicine characteristics - BOOTS CHILDRENS 3 MONTHS PLUS VAPOUR RUB, BOOTS MILD VAPOUR RUB 3 MONTHS PLUS
1 NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORMOintment
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For head colds, stuffy nose, cough and chest colds.
4.2 Posology and method of administration
For children over 2 years and adults
Apply a small amount on the chest and back particularly at bedtime. Rub gently and leave clothes loose for easy inhalation. Apply a moderate amount on older children and adults.
Elderly
There is no need for dosage reduction.
Children under 2 years
Not recommended for children under 2 years of age.
For topical application.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
Do not use on children under 2 years of age.
4.4 Special warnings and precautions for use
For external use only.
Do not apply around the nostrils, mouth, eyes or face.
Do not use on broken skin or wounds.
Keep all medicines out of the sight and reach of children.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
4.5. Interactions with other Medicaments and other forms of Interaction
No clinically significant drug interactions known.
4.6 Fertility, pregnancy and lactation
The safety of vapour rub during fertility, pregnancy and lactation has not been established. As a precaution this product should not be used without medical advice during pregnancy. This product should not be used on the mother’s chest during breastfeeding.
4.7. Effects on Ability to Drive and Use Machines
No adverse effects known.
4.8 Undesirable effects
Occasional hypersensitivity and irritant skin reactions.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseOver dosage may result in skin irritation.
Misuse:
Swallowing of the ointment might cause gastrointestinal symptoms like vomiting and diarrhoea. Treatment is symptomatic.
Following oral ingestion, symptoms of overdosage may include colic, dizziness, delirium, muscle twitching, epileptiform convulsions and depression of the central nervous system. Breathing may be difficult. There may also be haematuria and albuminuria.
Acute poisoning was observed after significant accidental consumption, with nausea, vomiting, abdominal pain, and headache, vertigo, feeling hot / flushing, convulsions, respiratory depression and coma.
Patients with severe gastrointestinal or neurological symptoms of poisoning should be observed and treated symptomatically. Do not induce vomiting.
Convulsions may be controlled by the intravenous administration of diazepam 5–10 mg.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Eucalyptus oil, camphor, levomenthol are volatile substances and are thought to produce an irritant effect on the respiratory tract, probably via a nasal/puhnonary arc.
5.2. Pharmacokinetic Properties
None stated.
5.3. Preclinical Safety Data
5.3. Preclinical Safety DataNot applicable.
6.1 List of excipients
White soft paraffin
6.2. Incompatibilities
None stated.
6.3. Shelf Life
36 months in amber glass jar.
20 months in polystyrene jar.
6.4. Special Precautions for Storage
Amber glass jar – None.
Polystyrene jar – Do not store above 25°C.
6.5. Nature and Contents of Container
Amber glass jar with either a tin plate cap with waxed aluminium faced pulpboard liner containing 45g or a thermoset plastic cap
or A polystyrene jar with an unlined polypropylene cap containing 25g or 45g.
6.6. Instruction for Use/Handling
6.6. Instruction for Use/HandlingNone.
7. MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham, NG2 3AA
8 MARKETING AUTHORISATION NUMBER(S)
PL 00014/0562
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
31 May 1996